NCT02109796

Brief Summary

Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance. We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

February 19, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

April 8, 2014

Last Update Submit

November 10, 2017

Conditions

Stroke

Keywords

tDCSStrokeForceSpasticityGaitEMGIsokinetic

Outcome Measures

Primary Outcomes (1)

  • maximum voluntary isometric strength of knee extensors

    The maximum voluntary isometric strength of paretic knee extensors will be evaluated with a isokinetic dynamometer, which measure peak torque.

    2 hours

Secondary Outcomes (5)

  • Resistive peak torque during passive knee flexion

    2h

  • Angle related to the resistive peak torque generation of the knee extensors

    2h

  • Amplitude of the interpolation twitch

    2h

  • EMG activation of the knee flexors and extensors during the strength evaluations (active and passive)

    2h

  • Functional evaluation of the gait performance and balance

    2h

Study Arms (2)

hemiplegic patient

EXPERIMENTAL

anodal transcranial direct current stimulation

Device: transcranial Direct current stimulation

patient control

SHAM COMPARATOR

Sham transcranial direct current stimulation

Device: transcranial Direct current stimulation

Interventions

transcranial Direct current stimulationDEVICE
hemiplegic patientpatient control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written consent
  • hemiparetic patient after stroke in chronic phase (\> 6 months)
  • capacity to walk with or without technical assistance
  • following rehabilitation program for lower limbs

You may not qualify if:

  • patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia
  • previous orthopedic surgery in paretic lower limb (\<6 moths)
  • usual tDCS contraindications
  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raymond Poincare Hospital

Garches, 92380, France

Location

Related Publications (1)

  • Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

    PMID: 33175411DERIVED

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Roche Nicolas, MD PH

    Raymond Poincaré Hospital

    PRINCIPAL INVESTIGATOR

  • Bensmail Djamel, MD PH

    Raymond Poincare Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 10, 2014

Study Start

February 19, 2015

Primary Completion

November 28, 2016

Study Completion

April 30, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

FR(1)